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A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00354562
First received: July 18, 2006
Last updated: January 5, 2011
Last verified: September 2010
History of Changes

July 18, 2006
January 5, 2011
February 2007
February 2008   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: Subjects may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Maximum Tolerated Dose
  • Progression-free Survival
Complete list of historical versions of study NCT00354562 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Time-to-Progression (TTP) [ Time Frame: Subject may remain on study until disease progression ] [ Designated as safety issue: No ]
  • Overall Survival
  • Response Rate
  • Duration of response
  • Time-to-Progression (TTP)
  • Quality of Life (QoL)
  • Treatment related toxicities
Not Provided
Not Provided
 
A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer
A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Drug: ABT-751
    200mg ABT-751 daily for 14 days every 21 days
  • Drug: Placebo
    Placebo daily for 14 days every 21 days
  • Drug: Docetaxel
    Standard Docetaxel every 21 days
    Other Name: Taxotere
  • Active Comparator: A
    Docetaxel + ABT-751
    Interventions:
    • Drug: ABT-751
    • Drug: Docetaxel
  • Placebo Comparator: B
    Docetaxel + placebo
    Interventions:
    • Drug: Placebo
    • Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
Not Provided
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically documented NSCLC
  • Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
  • Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
  • Only one prior anti-tumor treatment regimen in the curative setting
  • Progressive disease following the previous anti-tumor treatment regimen
  • Measurable disease by RECIST criteria
  • Brain metastasis must be stable and well-controlled

ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent

  • Only one prior anti-tumor treatment regimen in the curative setting
  • Progressive disease following the previous anti-tumor treatment regimen
  • Measurable disease by RECIST criteria
  • Brain metastasis must be stable and well-controlled
  • ECOG performance score 0-2
  • All anti-tumor therapy discontinued at least 3 weeks prior to study entry
  • All adverse events from prior treatment are resolved or stable
  • Adequate hematologic, renal, and hepatic function
  • Females must not be pregnant
  • Willing to take adequate measures to prevent pregnancy
  • Life expectancy of at least 3 months
  • Able to complete the Quality of Life questionnaire
  • Voluntarily signed informed consent

Exclusion Criteria:

  • Greater that Grade 1 neurological findings
  • Allergy to sulfa medications
  • Previous treatment with ABT-751 or docetaxel
  • Receipt of more than one investigational agent for NSCLC
  • Significant weight loss (>10%) within 6 weeks of study entry
  • Glucose-6-phosphate dehydrogenase deficiency or porphyria
  • Significant systemic disease that would adversely affect participation
  • Class 3-4 New York Heart Association classification status
  • Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Ireland,   United Kingdom
Puerto Rico
 
NCT00354562
M05-782, 2006-002838-38
No
Not Provided
Not Provided
Helen Eliopoulos, MD, Global Project Head, Abbott
Abbott
Not Provided
Study Director: Helen Eliopoulos, MD Abbott
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP